This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

A Modernized Approach to Prenatal Care in Low Risk Women

This study has been completed.
Information provided by (Responsible Party):
Allan Nadel, Massachusetts General Hospital Identifier:
First received: May 24, 2012
Last updated: February 3, 2017
Last verified: February 2017
The investigators plan to identify 80 pregnant women at low risk for obstetrical complications and replace 4-5 routine third trimester visits with a structured program of home weight, blood pressure and urine protein monitoring along with regular structured phone interviews and a 28 week ultrasound. The investigators hypothesis is that this protocol is both safe and acceptable.

Condition Intervention
Pre-eclampsia Intrauterine Growth Retardation Other: Modernized prenatal care

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Modernized Approach to Prenatal Care in Low Risk Women

Resource links provided by NLM:

Further study details as provided by Allan Nadel, Massachusetts General Hospital:

Primary Outcome Measures:
  • Unanticipated pregnancy complications [ Time Frame: Gestational age 18-36 weeks ]
    Any maternal and/or fetal adverse outcome that was not detected, but could have been detected by routine antepartum visits between 18 and 36 weeks

Enrollment: 4
Study Start Date: July 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low risk patients
Patients who agreed to 4 telemedicine obstetrical visits
Other: Modernized prenatal care
Home monitoring/phone surveillance/28 week ultrasound in place of 4-5 routine prenatal visits between 18 and 36 weeks


Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age < 35
  • Doesn't live alone
  • Current phone number
  • Previous pregnancy
  • No prior second trimester miscarriage/fetal loss after 13 weeks
  • Previous delivery
  • If yes, all had uncomplicated antepartum course
  • All Deliveries > 37 weeks
  • All birth weight > 2700 grams
  • Maternal BMI between 18.5 and 30
  • No chronic medical problems
  • No current substance abuse
  • Spontaneous conception
  • No family history of pre-eclampsia
  • Agrees to first trimester aneuploidy screening

Exclusion Criteria:

  • Clinically significant abnormalities on routine physical exam or routine laboratory results
  • Multiple pregnancy
  • Fetal abnormalities detected on either the 11-14 week or the 18 week ultrasound including a nuchal translucency > 3 mm but not including second trimester markers for aneuploidy or a low lying placenta
  • A risk of fetal aneuploidy on first trimester screening > 1:300 PAPP-A < 5 %ile or HCG < 1 %ile (abnormalities of these serum analytes routinely obtained as part of aneuploidy screening are associated with an increased risk of adverse outcome)
  • Elevated blood pressure (> 140/90),
  • Cervical length < 3 cm at the 18 week ultrasound (which is associated with an increased risk for preterm delivery).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01606774

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Allan S Nadel, MD Massachusetts General Hospital and Harvard Medical School
  More Information

Responsible Party: Allan Nadel, Director of Prenatal Diagnosis, Dept. of OB/GYN, Massachusetts General Hospital Identifier: NCT01606774     History of Changes
Other Study ID Numbers: PNC2.0
Study First Received: May 24, 2012
Last Updated: February 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes processed this record on September 21, 2017